The present invention relates to a hormonal agent or composition for skin treatment, especially seborrhea, Acne vulgaris, androgenically conditioned alopecia and androgenic symptoms of women.
In central Europe the incidence of hormonally conditioned skin diseases, such as acne, seborrhea and hirsutism, is estimated at 35 to 50%. These illnesses appear primarily in young men and women after puberty who are exposed to considerable suffering because of them (H. Hagen, et al, Klinische Erfassumg antiandrogener Effekte von Dienogest {Clinical Determination of antiandrogenic effects of dienogest}, pp. 223-230 in "Dienogest-Praklinik und Klinik eines neuen Gestagens", A. Teichmann, ed, Walter de Gruyter Verlag, Berlin, N.Y., 1995).
The sebaceous gland activity is considerably influenced by hormones. Testosterone and dihydrotestosterones are responsible for the sebocyte proliferation and sebogenesis and provide, as a result, the driving force for sebogenesis. An interaction with androgen receptors, which are localized in human skin (acne areas, such as the face, upper breast portions, the V-shaped region of the back and the outer sides of the upper arms), especially the sebaceous gland and sebaceous gland follicle, is, among other things, a prerequisite for this(R. Choudhry, et al, "Localization of androgen receptors in human skin by immunohistochemistry: implications for the hormonal regulation of hair growth, sebaceous gland and sweat glands", in J. Endocr. 133, pp. 467-475(1992); M. E. Sawaya, "Purification of androgen receptors in human sebocytes and hair", in J. Invest. Dermat. 98, pp. 92-96(1992).
Continuous sebum production increases in acne patients depending on the androgen secretions and the peripheral response of the end organs and reaches its highest value in Acne conglobata.
A hormonal agent or composition which is described in German Patent DE-PS 43 21 957 is used for acne therapy. This hormonal agent is a composition which is taken orally. Because of its systemic action undesirable effects and material accumulation occur in acne patients. Besides the hormonal treatment of acne it is also known to stimulate hair growth. In German Patent Document DE 36 15 396 a combination preparation comprising a hair tonic including cyproteron acetate in hair tonic is used as a combined preparation for treating the scalp skin and for promotion of hair growth.
The action of cyproteron acetate and chlormadinon acetate during therapeutic application is based on a centrally mediated antigonadotropic effect. Because of that an acne therapy and/or treatment of alopecia in humans is not possible with these active ingredients. Furthermore cyproteronic acetate and chlormadinon acetate causes a peripheral competitive androgen receptor blockage in acne of women (Ch. Luderschmidt, "Die Akne der Frau{The Acne of Women}" in Gynakol. Prax., 19, pp. 479-488, 1995).